The present invention relates to the field of medical devices. More specifically, the invention relates to a pillow that allows a positioning of a patient to minimize the interference with medical devices associated with the face.
Pillows are used during sleep both for comfort of a patient and to position a patient's head in a certain orientation. One purpose of pillows is to position the head of a patient so as to prevent obstruction of the patient's airway, particularly in treating mild sleep apnea and snoring. Sleep apnea refers to a collection of conditions and syndromes that are characterized by periods of apnea, or the temporary cessation of breathing. Sleep apnea syndromes may be classified into three main categories: central, obstructive, and mixed. Central sleep apnea refers to apnea syndromes with origins in the central nervous system. Obstructive sleep apnea (OSA) refers to apnea syndromes due primarily to the collapse of the upper airway during sleep. Mixed apnea refers to apnea with both central and obstructive characteristics.
In the case of OSA, a number of medical and surgical treatment options exist. Preferred nonpharmacologic treatments include weight reduction, tongue-retaining devices, and positive airway pressure modalities such as continuous positive airway pressure (CPAP) and bilevel positive airway pressure (BiPAP). Air pressure is prescribed in centimeters of water at a level sufficient to maintain an open patent airway in all positions and stages of sleep. CPAP involves the administration of air at a fixed positive pressure through the nose or mouth by an external device to maintain a clear upper airway. BiPAP is similar to CPAP, but it is capable of generating two alternating pressure levels, a higher inspiratory and lower expiratory. AutoPAP systems adjust or self-titrate through out the night based on body position and stage of sleep.
The symptoms of sleep apnea are most pronounced when a person afflicted with the condition sleeps in a supine position. Supine shall herein be defined as lying on the back or having the face upward. When a patient sleeps in a supine position, gravity causes the jaw and mandible to move downwardly. The downward movement of the jaw and mandible may block or obstruct the patient's airway. Occasionally the back of the tongue may also contribute to this obstruction. During bouts of extreme snoring (sometimes associated with sleep apnea), the uvula may also contribute to airway obstruction. During these periods of obstruction, the patient ceases to breathe normally, and carbon dioxide accumulates within the bloodstream until it causes an arousal from the sleeping patient to re-open the airway. The arousal may cause the person to move laterally, shake, or lurch, until the jaw, mandible, or tongue is repositioned and ceases to obstruct the airway or the relaxed muscles respond to reopen the collapsed airway.
A number of methods involving pillows have been proposed to alleviate this condition. U.S. Pat. No. 6,000,501, issued to Herrick, discloses a pillow that uses upper and lower tiers to support a patient's head at a selected angle or elevation from the horizontal. The pillow aims to prevent the patient's mandible, jaw, and tongue from the downward movement that contributes to sleep apnea and snoring while a the person sleeps on his or her back. Herrick's invention typifies the concept of preventing sleep apnea, through altering the position of the mandible.
Another approach may be found in U.S. Pat. No. 5,708,998, issued to Torbik, which discloses a cervical pillow with a central depression, neck rolls, and side cut-outs. The Torbik invention, while attempting to provide better air circulation for breathing, uses angled side edges that compress and expand laterally given the contents of Torbik's pillow. The neck roll assures that the patient's neck is placed along the bottom edge of the pillow.
U.S. Pat. No. 4,349,925, issued to Macomber, discloses a pillow with a head area, a chest area, and recesses for eye and nose clearance. Macomber's invention attempts to relieve pressure from a stomach sleeper's eyes, nose, throat, shoulders, and the blood vessels and glands of the neck. The pillow comprises a soft, yielding core, and is seamed to a tapered edge at its sides, notably the side supporting the face. The tapering of the pillow's sides gives it a collapsing effect onto the horizontal surface (or bed). Thus, while Macomber's invention may alleviate some pressure around the eyes, it ensures pillow or sheet contact with concerned areas of the face during sleep because of its collapsing effect. U.S. Pat. No. 3,667,074, issued to Emery, similarly discloses a pillow that collapses at its seamed sides.
U.S. Pat. No. 5,457,832, issued to Tatum, discloses a pillow that provides a central neck resting portion that claims to maximize the opening of a patient's oropharynx, thus alleviating a source of blockage. Tatum's pillow is configured to allow the patient's head to rest directly upon the mattress or on a thinner section of the pillow.
These examples illustrate the concept of preventing mild subclinical sleep apnea through positional means. The examples do so by addressing a patient's body from the neck up, utilizing various means to physiologically manipulate this region to prevent blockage. These examples do not address muscular airway collapse or obstructions caused by nonpositionally responsive physical anomalies, such as enlarged tonsils, adenoids, turbinates, etc.
Patients diagnosed with clinically significant OSA may be prescribed a positive air pressure delivery system, such as the CPAP, AutoPAP, or BiPAP systems mentioned herein, for use during sleep. The CPAP, AutoPAP, and BiPAP systems each comprise an airflow generator, hose, self-sealing nasal and/or oral interface, and provide a positive air stream to maintain an open air passageway for OSA patients. The effectiveness of the CPAP and BiPAP system concept as a treatment for sleep apnea is well documented. Medicare approved national coverage for CPAP treatment in 1986, soon after the inception of the treatment. The American Thoracic Society in 1994 published an official statement advocating the treatment, reporting that “CPAP is effective in the treatment of patients with clinically important obstructive sleep apnea/hypopnea syndrome.”
One drawback to these otherwise effective positive air pressure treatments involves the issue of keeping the mask sealed upon a patient's face, and specifically, the patient's nose and mouth. As the patient sleeps, a normal pillow or even those formerly exhibited tend to dislodge the seal around the patient's nose/mouth because the face and nose are constantly in contact with either the pillow or the horizontal surface. When the seal around the patient's nose and/or mouth breaks, air pressure is lost through the resulting leak, which in turn alters the prescribed therapeutic pressure. Another drawback with existing pillows is that such contact with the collapsing pillow or horizontal surface adds pressure to and irritates the facial areas adjoining the interface, impairing sleep for the patient and encouraging the patient to abandon therapy.
Because CPAP and BiPAP systems are relatively new, technology has yet to resolve the important issue of improving the user's ability to actuate CPAP and BiPAP systems effectively and efficiently during sleep. U.S. Pat. No. D250,985, issued to Armstrong, discloses a pillow with interesting features; however, Armstrong's patent issued well before the inception of CPAP technology and the issues stemming from it. Furthermore, Armstrong's vertical ridge coupled with its sharp side cutouts make it inappropriate for solving this particular problem of interface interference. If such a technology did exist to solve this problem, however, many of those who suffer from sleep apnea but have abandoned CPAP or BiPAP treatments could again seek viable treatment.
Thus, it can be seen that there is a need for an apparatus that facilitates the use of CPAP, AutoPAP and BiPAP treatments for sleep apnea patients during sleep. The apparatus should alleviate pressure between the interface and the patient's face, so that the seal of the interface on the patient's face is not compromised. The apparatus should also relieve irritation to the patient's face caused by pressure to the interface and afford the patient a comfortable, quality sleep. It is desirable that the apparatus be easy and inexpensive to manufacture.